Rollout IVDR 2022: How to prepare for the IVDR by May 2022? Date of Application or Dead on Arrival?

Complying with the new EU Requirements for IVD’s is expected to become very challenging for IVD manufacturers, some say even more than the MDR. The leaving point for many manufacturers is the IVD Directive that came into force in the year 2003. In the meantime, much has changed.

 As a result of the introduced IVDR, manufacturers that currently place IVD’s on the EU Community market will encounter the new reality; facing scrutiny by EU Notified Bodies and Competent Authorities, installing a Person Responsible for Regulatory Compliance, carrying out additional testing and even performance investigations. For a large portion of the IVD manufacturers, this reality will be apparent as of the date of application - 26 May 2022 - since a large portion of IVD devices will need to comply after that date without the reliance on market access through the current IVDD certificate. Although this date may still seem to be far in the future, there is a lot that IVD manufacturers need to do in order to prepare. 

 This workshop will cover these big themes of the IVDR alongside with hands-on information on how to tackle the most important requirements. Elements that are going to be covered are:

• Most important elements of the IVDR and focus areas when implementing
• Developing a strategy for regulatory compliance in accordance to the IVDR
• Performance Evaluation process and documentation requirements
• Reviewing and effectively implementing IVDR requirements into Technical dossiers and QMS
• Integrating Risk Management and Post Market Surveillance into the QMS
• Management of the implementation of the IVDR project

The potential impact of the IVDR for new and existing (legacy) devices will be discussed together with important considerations for determining the appropriate regulatory pathway and application strategy

Pricing Amounts & Deadlines

From now–12 September 2021: Early Bird Member €660 | Nonmember €740 

13 September 2021-13 Oktober 2021: Regular Member €740 | Nonmember €825

Objectives

Upon completion of this session, participants should be able to:

• Understand the most important requirements of the IVDR and how this affects product compliance.
• Understand how to implement these requirements in your QMS and technical dossier.
• Develop a good understanding on how to develop a sound regulatory strategy for your device.
• Understand how to apply with a Notified Body once all the preparations are done.

Who Should Attend?

Regulatory affairs professionals (entry level, specialists, managers and directors)

Instructional Flow

We will use a traditional slide presentation combined with practical worked examples and case studies to engage attendees throughout the session as well as encouraging attendees to come forward with their own practical questions. 

Key words: Notified Bodies, Clinical Evidence, EU Market Surveillance, PRRC, Quality Systems, Technical Documentation, Post Market Surveillance

Workshop leader

Alex Laan
Principal Consultant
NAMSA

Alex Laan currently holds the position of Principal Consultant at NAMSA. Until recently, Alex worked as Principal Certification Manager at DEKRA Certification BV, Notified Body for (IVD) Medical Devices located in Arnhem, The Netherlands. After starting at KEMA Quality in 2006, Alex was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVD's and Medical Devices, including drug-device combinations. Active member of IVD working group within EU Notified Bodies and TEAM-NB. Acting as direct contact for EU competent authorities. Alex has an education as engineer (Dipl.-Ing) in Bioprocesstechnology and Biochemistry. Previously, Alex worked as a product specialist in immunohematological products and plasma products with Sanquin Blood Transfusion Services, Amsterdam, after which he started his career working as a QA and RA manager for IVD Medical devices at Meddens Diagnostics / IBL Hamburg.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.